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01.12.2018 | News item

Mylan's valsartan products banned from EU medicines

Erschienen in: Reactions Weekly | Ausgabe 1/2018

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Excerpt

Mylan Laboratories in India can no longer provide batches of valsartan for use in EU medicines due to the presence of NDEA¹ as an impurity, says the EMA. …

NDEA = N-nitrosodiethylamine

CEP is a certificate of compliance with European standards for quality testing.

Also see Reactions 1711 p2; 803335025, see Reactions 1715 p1; 803341056, see Reactions 1717 p3; 803343140 and see Reactions 1725 p1; 803353257

European Medicines Agency. Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity. Internet Document : [2 pages], 19 Nov 2018. Available from: URL: https://www.ema.europa.eu/en/news/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity

Titel: Mylan's valsartan products banned from EU medicines
Publikationsdatum: 01.12.2018
Verlag: Springer International Publishing
Erschienen in: Reactions Weekly / Ausgabe 1/2018
Print ISSN: 0114-9954
Elektronische ISSN: 1179-2051
DOI: https://doi.org/10.1007/s40278-018-54902-8

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Mylan's valsartan products banned from EU medicines

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Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

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